Effect of Lifestyle Intervention vs Physical Therapy Treatment in Patients With Secondary Lymphedema After Cancer

Participants with lymphedema secondary to cancer treatment will participate in a two week rehabilitation programme focusing on physical therapy treatment and a two week programme focusing on physical exercise. The purpose is to assess the effect of the rehabilitation programmes on lymphedema and measures of physical performance.

Study Overview

• Status: Completed
• Conditions: Lymphedema, Secondary
• Intervention / Treatment: Other: Physical therapy treatment; Behavioral: Lifestyle treatment

Detailed Description

Traditionally, physical therapy treatment, e.g. manual lymphatic drainage and compression bandaging is used for treatment of cancer treatment induced lymphedema. Alternatively, lifestyle interventions are used as treatment, with focus on physical exercise. However, the effects of such interventions are scarcely documented. Thus, the purpose of this study is to assess the effect of physical therapy treatment and physical exercise on lymphedema and measures of physical performance.

The study will be performed in a randomized cross-over design, encompassing 26 participants with secondary lymphedema related to cancer treatment. Firstly, half of the participants in the intervention group will be randomized to a two week rehabilitation programme focusing on physical activity while the other half to a rehabilitation programme focusing on physical therapy treatment, and the other way around three months later. In addition. there will be a control group with cancer related lymphedema not participating in any rehabilitation programme. Pre and post of each of the two week rehabilitation periods the following measurements will be performed: The magnitude of lymphedema by volume measurements of the limbs (by DXA); measurements of maximal strength, range of movement, flexibility, balance, physical functionality and questionnaires about perceived health and level of physical activity.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Lillehammer, Norway
    • Inland Norway University of Applied Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Secondary lymphedema in arm or/and leg related to cancer

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical therapy treatment	Other: Physical therapy treatment; Two weeks rehabilitation programme focusing on physical therapy treatment, e.g. manual lymphatic drainage and compression bandaging
Experimental: Lifestyle treatment	Behavioral: Lifestyle treatment; Two weeks rehabilitation programme focusing on physical activity
No Intervention: Control; Parallel control group, not undertaking any treatment and not part of the cross-over design

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lymphedema	Ratio of the volume of affected limb vs volume of nonaffected limb measured by DXA	Change from before to the end of each of the two week rehabilitation programmes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal strength	In handgrip and knee-extension	Measured immediately before and at the end of each of the two week rehabilitation programmes.
Balance	One leg balance test	Measured immediately before and at the end of each of the two week rehabilitation programmes.
Flexibility in hip and back	Sit and reach test	Measured immediately before and at the end of each of the two week rehabilitation programmes.
Flexibility in shoulder	Back scratch test	Measured immediately before and at the end of each of the two week rehabilitation programmes.
Test of physical functionality	Stand up and walk test	Measured immediately before and at the end of each of the two week rehabilitation programmes.
Range of joint movement in the knee, degrees of movement measured with a protractor	Range of joint movement in the knee	Measured immediately before and at the end of each of the two week rehabilitation programmes.
Range of joint movement in the elbow, degrees of movement measured with a protractor	Range of joint movement in the elbow	Measured immediately before and at the end of each of the two week rehabilitation programmes.
Self perceived health	Perceived health assessed by questionnaire	Measured immediately before and at the end of each of the two week rehabilitation programmes.
Level of physical activity	Level of physical activity assessed by questionnaire	Questionnaire will be completed immediately before the rehabilitation programmes, assessing the level of physical activity the prior three months.

Collaborators and Investigators

• Sponsor: Inland Norway University of Applied Sciences
• Collaborators: Montebellosenteret, Mesnali, Norway

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2019
• Primary Completion (Actual): April 4, 2020
• Study Completion (Actual): April 4, 2020

Study Registration Dates

• First Submitted: November 11, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Lymphatic Diseases; Neoplastic Processes; Lymphedema; Neoplasm Metastasis
• Other Study ID Numbers: Montebello19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No